Vaccine Safety: Six Common Misconceptions : Part 3

by CDC

(Page 3 of 4)

All vaccine manufacturing facilities and vaccine products are licensed by the FDA. In addition, every vaccine lot is safety-tested by the manufacturer. The results of these tests are reviewed by FDA, who may repeat some of these tests as an additional protective measure. FDA also inspects vaccine-manufacturing facilities regularly to ensure adherence to manufacturing procedures and product-testing regulations, and reviews the weekly VAERS reports for each lot searching for unusual patterns. FDA would recall a lot of vaccine at the first sign of problems. There is no benefit to either the FDA or the manufacturer in allowing unsafe vaccine to remain on the market. The American public would not tolerate vaccines if they did not have to conform to the most rigorous safety standards. The mere fact is that a vaccine lot still in distribution says that the FDA considers it safe.

4. Vaccines cause many harmful side effects, illnesses, and even death - not to mention possible long-term effects we don't even know about.

Vaccines are actually very safe, despite implications to the contrary in many anti-vaccine publications (which sometimes contain the number of reports received by VAERS, and allow the reader to infer that all of them represent genuine vaccine side-effects). Most vaccine adverse events are minor and temporary, such as a sore arm or mild fever. These can often be controlled by taking acetaminophen before or after vaccination. More serious adverse events occur rarely (on the order of one per thousands to one per millions of doses), and some are so rare that risk cannot be accurately assessed. As for vaccines causing death, again so few deaths can plausibly be attributed to vaccines that it is hard to assess the risk statistically. Of all deaths reported to VAERS between 1990 and 1992, only one is believed to be even possibly associated with a vaccine. Each death reported to VAERS is thoroughly examined to ensure that it is not related to a new vaccine-related problem, but little or no evidence suggests that vaccines have contributed to any of the reported deaths. The Institute of Medicine in its 1994 report states that the risk of death from vaccines is "extraordinarily low."

DTP Vaccine and SIDS

One myth that won't seem to go away is that DTP vaccine causes sudden infant death syndrome (SIDS). This belief came about because a moderate proportion of children who die of SIDS have recently been vaccinated with DTP; and on the surface, this seems to point toward a causal connection. But this logic is faulty; you might as well say that eating bread causes car crashes, since most drivers who crash their cars could probably be shown to have eaten bread within the past 24 hours.

If you consider that most SIDS deaths occur during the age range when 3 shots of DTP are given, you would expect DTP shots to precede a fair number of SIDS deaths simply by chance. In fact, when a number of well-controlled studies were conducted during the 1980's, the investigators found, nearly unanimously, that the number of SIDS deaths temporally associated with DTP vaccination was within the range expected to occur by chance. In other words, the SIDS deaths would have occurred even if no vaccinations had been given. In fact, in several of the studies children who had recently gotten a DTP shot were less likely to get SIDS. The Institute of Medicine reported that "all controlled studies that have compared immunized versus nonimmunized children have found either no association . . . or a decreased risk . . . of SIDS among immunized children" and concluded that "the evidence does not indicate a causal relation between [DTP] vaccine and SIDS."

But looking at risk alone is not enough - you must always look at both risks and benefits. Even one serious adverse effect in a million doses of vaccine cannot be justified if there is no benefit from the vaccination. If there were no vaccines, there would be many more cases of disease, and along with them, more serious side effects and more deaths. For example, according to an analysis of the benefit and risk of DTP immunization, if we had no immunization program in the United States, pertussis cases could increase 71-fold and deaths due to pertussis could increase 4-fold. Comparing the risk from disease with the risk from the vaccines can give us an idea of the benefits we get from vaccinating our children.

The fact is that a child is far more likely to be seriously injured by one of these diseases than by any vaccine. While any serious injury or death caused by vaccines is too many, it is also clear that the benefits of vaccination greatly outweigh the slight risk, and that many, many more injuries and deaths would occur without vaccinations. In fact, to have a medical intervention as effective as vaccination in preventing disease and not use it would be unconscionable.

Research is underway by the U.S. Public Health Service to better understand which vaccine adverse events are truly caused by vaccines and how to reduce even further the already low risk of serious vaccine-related injury.

About the Author

www.cdc.gov
The Centers for Disease Control and Prevention (CDC) is one of the 13 major operating components of the Department of Health and Human Services (HHS), which is the principal agency in the United States government for protecting the health and safety of all Americans and for providing essential human services, especially for those people who are least able to help themselves.